Super Colon Cleanse
NDC 57348-897
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
Super Colon Cleanse is a OTC MONOGRAPH DRUG-approved product labeled by Health Plus Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a brown product. This product entry covers the primary NDC 57348-897 and 4 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
57348-897
Proprietary Name:
Super Colon Cleanse
Product Type: [3]
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
57348
Product Label ID:
FDA Application Number: [6]
505G(a)(3)
Marketing Category: [8]
OTC MONOGRAPH DRUG
Marketing Timeline
Start Marketing Date: [9]
09-16-2018
End Marketing Date: [10]
04-30-2026
Listing Expiration Date: [11]
04-30-2026
Exclude Flag: [12]
D
Product Characteristics
Color(s):
BROWN (C48332)
Shape:
CAPSULE (C48336)
Size(s):
16 MM
Score:
1
Code Structure Chart
Product Details
What is NDC 57348-897?
The NDC code 57348-897 is assigned by the FDA to the product Super Colon Cleanse. This pharmaceutical product is labeled by Health Plus Inc. and is currently categorized as listed product. In terms of distribution, this product is available in 4 different package configurations. The associated package NDC(s) include: 57348-897-10, 57348-897-12, 57348-897-24, 57348-897-60. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
Take this product with a full glass (8oz) of water or other liquid. Taking this product without enough liquid may cause choking. (See choking warning.) adults and children 12 years of age and older: 2 capsules 2 times daily children 6 to under 12 years of age: 1 capsule once or twice daily children under 6 years of age: consult a doctor
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- SENNOSIDES (UNII: 3FYP5M0IJX)
- SENNOSIDES (UNII: 3FYP5M0IJX) (Active Moiety)
Which are the Inactive Ingredients associated UNII Codes?
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:
- GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
* Please review the full disclaimer at the bottom of this page.
Patient Education
Senna
Senna is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures. Senna is in a class of medications called stimulant laxatives. It works by increasing activity of the intestines to cause a bowel movement.
[Learn More]
Senna
What is it? Senna is the fruit (pod) or leaf of the plant Senna alexandrina. It is approved in the US as a laxative for short-term treatment of constipation.
Senna contains many chemicals called sennosides. Sennosides irritate the lining of the bowel, which causes a laxative effect.
Senna is an FDA-approved over-the-counter (OTC) laxative. It is used to treat constipation and also to clear the bowel before procedures such as colonoscopy. People also use senna for irritable bowel syndrome (IBS), hemorrhoids, weight loss, and many other conditions, but there is no good scientific evidence to support these uses.
[Learn More]
* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
